EP0855192B1 - Reperfusion device - Google Patents

Abstract

A method of mixing blood taken from a patient with a fluid, to be returned to the patient's blood vessels, involves holding a given volume of the extracted blood in a flexible bag (1) which can be emptied by compression. Separately, the additional fluid is drawn from a supply point (26) into a second (2) and similar bag. The contents of the first bag are transferred to the second bag by squeezing it out manually before or after the second bag has been charged. The mixture in the second bag is squeezed out. Also claimed is the device for carrying out the method, having at least two flexible bags (1,2), which can be emptied by squeezing and compression. The first bag is linked to the patient by a catheter (8,14) for blood extraction. The bags are linked by a tube, so that their contents can be transferred. The second bag is linked by a tube to the supply (26) of added fluid for a given vol. to be passed into the bag. A tube (32) gives a link between the second bag and the final bag, if in place. A tube (40,46) takes the blood and fluid mixture from the second bag. An optical scale (4,6) shows the volumes present in the bags. Closures (10,24,34,42) are opened and closed selectively to control the flow through the tubes (22,32) and catheters (8,14,40,46).

Description

The invention relates to a reperfusion device.

DE 38 20 840 C1 describes an aqueous reperfusion solution for reducing reperfusion damage after acute, peripheral A patient's vascular occlusion is known. EP 0 513 071 B1 discloses a reperfusion device for reperfusion of blood vessels, which has the following features: a catheter which can be inserted into a blood vessel, a blood withdrawal device for withdrawing oxygenated arterial blood from a patient, means for mixing a reperfusion solution with that of the patient withdrawn blood, a mechanical pumping device for conveying the mixture of blood and reperfusion solution through the catheter into the blood vessel, and a pressure measuring means arranged at the tip of the catheter in the form of a pressure measuring lumen or a pressure probe. Various methods are known for removing vascular occlusions. Despite successful restoration of the bloodstream, morbidity and mortality after such a vascular procedure are relatively high. The main cause of this is reperfusion damage, ie tissue damage that occurs when the blood flows through the artery again with the full arterial pressure generated by the heart after removal of the vascular occlusion. This disadvantage is prevented or substantially reduced by using the aforementioned reperfusion solution if, for example with the aforementioned reperfusion device, it is introduced into the vessel for a longer period of time, for example 30 minutes and under reduced pressure, after the vessel closure has been removed, before the vessel is again connected with the full arterial pressure.

The object of the invention is to provide a possibility by which reperfusion can be carried out using means which are less expensive and easier to handle than the known methods and devices.

This object is achieved according to the invention by the characterizing features of independent claim 1.

Further features of the invention are contained in the subclaims.

The invention provides a device, in particular a set for reperfusion, in particular for reperfusion on a patient's leg, which is more acceptable for vascular surgery than the previously known means in terms of cost-effective manufacture and ease of handling. In principle, it is the use of two bags. The first bag is filled with the blood from the pelvic artery. This blood is then conveyed into the second bag, in which a certain amount of a reperfusion liquid has previously been filled. This mixture of blood and reperfusion fluid is then passed into the leg artery for a predetermined period of time and at a predetermined pressure. This process is repeated several times. Everything runs without a pump, because each bag is directly by hand or indirectly through one of the Hand operated compressed air sleeve being compressed. Blood pressure is measured in the delivery line from the second bag to the leg or in a delivery cannula with which the mixture is introduced into the leg artery. Depending on the pressure size of the blood in the leg artery, the pressure in the supply line is regulated by more or less strong pressure on the second bag. Because heparin is not used for this treatment, all bags, tubes, catheters and other elements that come into contact with the blood or the mixture of blood and reperfusion fluid must be provided with a heparin coating.

Fig. 1

schematisch ein Set oder eine Vorrichtung zur Reperfusion gemäß der Erfindung,

Fig. 2

schematisch eine weitere Ausführungsform der Erfindung.

The invention is described below with reference to the drawings based on preferred embodiments. The drawings show in

Fig. 1

schematically a set or a device for reperfusion according to the invention,

Fig. 2

schematically another embodiment of the invention.

The set shown in Fig. 1 for reperfusion of blood vessels contains two commercially available, hand-compressible flexible bags 1 and 2, which consist of transparent or at least light-translucent, flexible material and each have at least one level mark 4 or 6. Because the bags are transparent or at least translucent to light, an operator can see whether the level of a liquid in the bags has already reached a desired height relative to marking 4 or 6.

The first bag 1 has a blood withdrawal tube 8, which can be optionally closed or opened with a closure element 10, preferably a hose clamp, and connects an inlet 12 of the bag 1 in the upper portion of the bag to a blood withdrawal catheter 14. The blood withdrawal catheter 14 is inserted into an artery 16 of the patient so that blood can be conveyed into the first bag 1 up to the desired marking 4 by the blood pressure in the artery when the closure element 10 is open.

An inlet 20 at the upper end section of the second bag 2 is connected to a container 26 in which reperfusion liquid is located via a reperfusion liquid supply hose 22, which can optionally be opened or closed by a closure element 24, preferably in the form of a hose clamp. By opening the closure element 24, reperfusion liquid can be filled into the second bag 2 until the reperfusion liquid in the second container 2 has reached a predetermined fill level at its height marking 6.

An outlet 30 at the lower end of the first bag 1 is connected to a second inlet 36 at the upper end portion of the second bag 2 by a connecting hose 32, which can be optionally closed or opened by a closure element 34, preferably a hose clamp. As a result, when the blood collection tube 8 and the reperfusion fluid supply tube 22 are closed by their closure elements 10 and 24, a metered amount of blood can be transferred from the first container 1 to the second container 2 and mixed there with the previously metered amount of reperfusion fluid. when the closure element 34 of the connecting hose 32 is opened. The metered amount of blood is preferably the amount that was previously filled into the first bag 1 by the artery 16 up to the predetermined height marking 4.

A reperfusion tube 40, which can optionally be closed or opened at its upstream end by a closure element 42, preferably a hose clamp, is connected at its upstream end to an outlet 44 at the lower end of the second bag 2 and has at its downstream end a reperfusion catheter 46 which can be inserted into the same artery 16 or into another artery of the same patient upstream from where a vasoconstriction or occlusion 48 has previously been removed. The arterial blood flow direction is shown by arrows 50. This allows through Opening the closure element 42 of the reperfusion tube 40, if the closure elements 24 and 34 of the reperfusion fluid supply tube 22 and the connecting tube 32 were previously closed, the previously metered amount of blood and reperfusion fluid from the second container 2 through the reperfusion catheter 46 into the Artery are promoted, with a predetermined pressure and for a predetermined period of time. This pressure is optically displayed by a pressure measuring device 52, which is connected to the reperfusion liquid supply tube 40 or, preferably, directly to the reperfusion catheter 46 and indicates the pressure therein. The length of time during which the mixture of blood and reperfusion fluid is introduced into the blood vessel, such as artery 16, can be read by an operator on any watch and can be, for example, about 30 minutes.

To empty the blood from the first container 1 into the second container 2, the first container 1 is compressed by an operator. In the same way, to empty the blood-reperfusion liquid mixture from the container 2 into the artery 16, this container 2 is compressed by an operator. The compression of the two bags 1 and 2 can be done by hand either by pressing the hand directly on the bag 1 or 2, or by the bags 1 and 2 in one Stand squeezing device or be surrounded by a squeezing device, preferably a commercially available pressure cuff which can be inflated by hand by an operator. 1 shows a pressure cuff 54 with a manually operable bellows, balloon or air pump 56 for selectively inflating or deflating the pressure cuff 54 in order to thereby compress the first bag 1 or to unfold it again. In the same way, the second bag 2 is preferably also surrounded by a commercially available pressure sleeve 54, which has a hand-operated bellows, balloon or air pump 56, for selectively inflating or deflating this pressure sleeve 54 and thus for optionally compressing or unfolding the second bag 2. The pressure cuffs 54 are only shown schematically and are not described in detail since they are known, commercially available elements.

The two bags 1, 2, all tubes 8, 22, 32, 40, all tube clips 10, 34, 42, and the two catheters 14, 46 are commercially available parts. Because heparin is not used in the removal of vascular occlusions and in reperfusion, all surfaces that come into contact with blood, in particular the inner surfaces of bags 1 and 2 and lines 8, 14, 32 and 40, must be provided with a layer of heparin ,

• 1. Schritt, Einbringen von Blut in den ersten Beutel 1 bis zu einer bestimmten Marke seiner Füllstands-Höhenmarkierung 4;
• 2. Schritt, unabhängig vom ersten Schritt, vor, gleichzeitig mit oder nach dem ersten Schritt, Fördern von Zusatzflüssigkeit aus dem Zusatzflüssigkeits-Behälter 26 in den zweiten Beutel 2 bis zu einer vorbestimmten Marke seiner Höhenmarkierung 6;
• 3. Schritt, Übertragen einer vorbestimmten dosierten Menge des Blutes aus dem ersten Beutel 1 in den zweiten Beutel 2, nachdem zuvor in den zweiten Beutel 2 eine vorbestimmte dosierte Menge der Zusatzflüssigkeit eingebracht wurde;
• 4. Schritt, Entleeren der Mischung aus Blut und Zusatzflüssigkeit oder einer dosierten Menge der Mischung aus dem zweiten Beutel.

The following procedure for mixing blood and an additional liquid for reperfusion of blood vessels can be carried out:

• 1st step , introducing blood into the first bag 1 up to a certain mark of its level mark 4;
• 2nd step , regardless of the first step, before, simultaneously with or after the first step, conveying additional liquid from the additional liquid container 26 into the second bag 2 up to a predetermined mark on its height marking 6;
• 3rd step , transferring a predetermined metered amount of blood from the first bag 1 into the second bag 2 after a predetermined metered amount of the additional liquid has been introduced into the second bag 2;
• 4th step , emptying the mixture of blood and additional liquid or a metered amount of the mixture from the second bag.

Instead of the level markings 4 and / or 6, the two bags 1 and 2 can have other means, for example floats or electrical elements, which indicate the level of the bags 1 and 2. In this case, bags 1 and 2 may not need to be made of transparent or translucent material. The level indicators are used to mix a metered amount of blood with a metered amount of reperfusion liquid and a metered amount Dispense the amount of such a mixture through the reperfusion catheter 46.

Bags 1 and 2 can be used which have no level indicator (4, 6 or others) if the metered quantities can be defined differently. For example, FIG. 2 shows a preferred embodiment in which the container 26 has fill level display means 56. The metered amount of reperfusion liquid which is transferred from the container 26 into the second bag 2 can be optically read from this. In this case, the second bag 2 need not have a level indicator 6.

The container 26 may be made of transparent or translucent material and its level indicator 56 may be markings provided on it.

According to yet another preferred embodiment, the first bag 1 need not have a level indicator, for example 4, if at least the second bag 2, or this second bag 2 and the container 26 have (6, 56). In this case, as much blood can first be transferred from the first bag 1 into the second bag 2 through the tube 32 until a certain fill level is reached in the second bag 2; then as much reperfusion liquid is transferred from the container 26 into the second bag 2 until a certain second fill level is reached in the second bag 2 or until the level in the container 26 has dropped to a certain value.

Since it is difficult to completely empty the second bag 2, its level indicator 6 is not a reliable measure of precisely metered amounts. Therefore, the blood is preferably metered through the level indicator 4 of the first bag 1 and the reperfusion liquid is metered through the level indicator 56 of the container 26.

Further bags of the same type can be connected to the second bag 2 in order to add further liquids in metered amounts to the blood.

Instead of the preferred hose clamps 10, 24, 34 and 42, taps, valves or other closure means can be used.

Claims (10)

1. Reperfusion device for the reperfusion of blood vessels of a patient, using means for removing blood from the patient, for mixing the removed blood with a reperfusion solution in a predetermined mixing ratio, and for conveying the mixture into the relevant blood vessel, characterised in that at least two pouches (1, 2) made from flexible material are provided, which can be pressed together for emptying and can then be erected again before renewed filling; in that a first (1) of these pouches (1, 2) is provided with a blood-removal catheter line (8, 14) for blood removal from the patient; in that the pouches (1, 2) are connected to one another in each case by a hose, so that a predetermined quantity of blood of the first pouch (1) can be transferred into the last pouch (2); in that a supply container (26) for reperfusion liquid is connected to one of the pouches (2), with the exception of the first pouch (1), via a hose, so that a predetermined quantity of reperfusion liquid can be transferred from the supply container (26) to this pouch (2), wherein this pouch (2), if it is not the last pouch (2), is connected according to flow to the last pouch (2) via a hose (32) to transfer this metered quantity of reperfusion liquid; in that the last pouch (2) is provided with a reperfusion catheter line (40, 46) in order to release from it a metered quantity of a mixture consisting of the metered quantity of blood and the metered quantity of reperfusion liquid; in that means (4, 6, 56) for visual display of the metered quantity of blood and the metered quantity of reperfusion liquid are provided; in that closure elements (10, 24, 34, 42) are provided for alternate opening or closing ofthe flow paths which are formed by the hoses (22, 32) and catheter lines (8, 14, 40, 46).
2. Reperfusion device according to claim 1, characterised in that at least one of the pouches (1, 2) consists of a transparent or light-transparent material, so that its filling level can be seen visually from the outside.
3. Reperfusion device according to claim 2, characterised in that the transparent or light-transparent pouch or pouches (1, 2) is provided or are provided with a filling level height marking (4, 6).
4. Reperfusion device according to one of the preceding claims, characterised in that at least one of the pouches (1, 2) consists of plastic.
5. Reperfusion device according to one of the preceding claims, characterised in that the supply container (26) has filling level display means (56).
6. Reperfusion liquid according to claim 5, characterised in that the supply container (26) consists of transparent or light-transparent material, and in that the filling level display means have a filling level height marking (56) on the supply container (26).
7. Reperfusion device according to one of the preceding claims, characterised in that at least one of the pouches (1, 2) is provided with a pressure cuff (54) which can be inflated by hand and then can be relieved again in order alternately to press it together and then to unfold it again.
8. Reperfusion device according to one of the preceding claims, characterised in that at least one of the closure means (10, 24, 34, 42) is a hose clip.
9. Reperfusion device according to one of the preceding claims, characterised in that all surfaces coming into contact with blood, in particular the inner surfaces of the pouches (1, 2) and the lines (8, 14, 32, 40, 46), are provided with a layer of heparin.
10. Reperfusion device according to one ofthe preceding claims, characterised in that the reperfusion catheter line (40, 46) is provided with a pressure-measuring device (52) for the visual display of the pressure prevailing in it.